BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ANX ROBOTICA CORP.

    Reg #: 3016544248 · FEI: 3016544248 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    17
    Establishment Types
    4
    Classifications
    6

    Registration Details

    Registration Name
    ANX ROBOTICA CORP.
    Registration Number
    3016544248
    FEI Number
    3016544248
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6010 W. Spring Creek Pkwy
    City
    Plano
    State
    TX
    ZIP
    75024
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230694

    Owner / Operator

    Firm Name
    AnX Robotica Corp.
    Operator Number
    10062363
    Address
    6010 W. Spring Creek Pkwy
    City
    Plano
    State
    TX
    Postal Code
    75024
    Country
    US
    Correspondent
    Tim Thomas

    Products

    Device Name Product Code
    Magnetically Maneuvered Capsule Endoscopy System QKZ
    System, Gastrointestinal Motility (Electrical) FFX
    Gastrointestinal Motility System, Capsule NYV
    Gastrointestinal Capsule Endoscopy Analysis Software Device QZF
    System, Imaging, Gastrointestinal, Wireless, Capsule NEZ
    Tether Accessory For Use In The Gastrointestinal Tract QUN

    Proprietary Names

    NaviCam Xpress with GastroScan NaviCam Xpress Stomach Capsule Endoscope System NaviCam Xpress Stomach System NaviCam Xpress System NaviCam Tether NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether IntraMarX 3D Radiopaque Marker MotiliCap GI Monitoring System ProScan AI Software NaviCam Xpress - 915 MHz Capsule NaviCam Stomach System NaviCam Capsule Endoscope System with NaviCam Stomach Capsule NaviCam Xpress - Lower Age Higher BMI Indication NaviCam Small Bowel Capsule Endoscopy System IntraMarX Radiopaque Markers NaviCam Capsule/Tether

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device